JP6995765B2 - Drape used with medical treatment systems - Google Patents

Description

Cross-reference to related applications This application is a benefit of the application of U.S. Provisional Patent Application No. 62 / 301,900, entitled "Drape for us with Medical Therapy Systems," filed March 1, 2016. Is claimed under Section 119 (e) of the United States Patent Act, and this specification is incorporated herein by reference for all purposes.

The invention described in the appended claims generally relates to a tissue treatment system and, in more detail, without limitation, a first bond strength, a second bond strength and a third bond. With respect to drapes with strength.

Clinical studies and practice have shown that decompression in the vicinity of the tissue site can enhance and accelerate the growth of new tissue at the tissue site. There are many applications of this phenomenon, but it has proven to be particularly advantageous in the treatment of wounds. Proper care of the wound, whether trauma, surgery, or another cause, is important to the outcome. Treatment of wounds or other tissues with decompression is commonly referred to as "negative pressure wound therapy", such as "negative pressure wound therapy", "decompression therapy", "vacuum therapy", "vacuum assisted closure". , And other names, including "local negative pressure". Negative pressure therapy can provide a number of benefits, including migration of epithelial and subcutaneous tissue, improved blood flow, and subtle deformation of tissue at the wound site. Combined with these advantages, granulation tissue development can be enhanced and healing time can be shortened.

It is also widely accepted that washing tissue sites can be extremely beneficial for the growth of new tissue. For example, the wound can be washed with a stream of liquid solution, or the cavity can be washed with a liquid solution for therapeutic purposes. These practices are commonly referred to as "irrigation" and "washing," respectively. "Intravenous drip" is another practice that generally refers to the process of slowly introducing a fluid into a tissue site and leaving the fluid for a predetermined period of time before removing the fluid. For example, infusion of a topical therapeutic solution onto the wound bed can be combined with negative pressure therapy to further promote wound healing by relaxing soluble contaminants in the wound bed and removing infectious substances. As a result, soluble bacterial load can be reduced, contaminants can be removed, and wounds can be washed.

Although the clinical benefits of negative pressure therapy and / or infusion therapy are widely known, improvements in treatment systems, components, and processes may benefit healthcare providers and patients.

New and useful systems, devices, and methods for covering tissue sites are described in the appended claims. Also illustrated embodiments are provided to allow one of ordinary skill in the art to create and use the claimed subject matter.

For example, some embodiments describe drapes for medical use. The drape can include a film layer having a first side surface and a second side surface, and an adhesive layer bonded to the first side surface of the film layer. The adhesive layer has a first adhesive strength before the application of the drape, a second adhesive strength in response to the force applied to the drape, and a second after the adhesive layer is exposed to electromagnetic radiation within the visible light spectrum. It can have an adhesive strength of 3. The drape can also include a barrier layer that is detachably bonded to the second side of the film layer. The barrier layer can be configured to block at least a portion of the electromagnetic radiation within the visible light spectrum.

More generally, a system for providing negative pressure therapy will be described. The system can include a manifold configured to be positioned above the tissue site and a drape configured to be positioned above the manifold and sealed to the mounting surface surrounding the tissue site. .. The drape can include a backing layer having a first side surface and a second side surface, and a mounting layer coated on the first side surface of the backing layer. The mounting layer has a first adhesive strength before the application of the drape, a second adhesive strength in response to the force applied to the drape, and a third after exposure of the mounting layer to electromagnetic radiation within the visible light spectrum. It may have adhesive strength. The drape can also include a strippably bonded filter layer on the second side of the backing layer. The filter layer is configured to block at least a portion of the electromagnetic radiation in the visible light spectrum. The system can also include a negative pressure source configured to be fluidly coupled to the manifold.

Alternatively, other exemplary embodiments may illustrate methods for treating tissue sites. The tissue interface can be positioned above the tissue site and the sealing member can be positioned above the tissue interface. The sealing member has a first adhesive strength before application of the sealing member, a second adhesive strength in response to a force applied to the sealing member, and after exposure of the first layer to electromagnetic radiation within the visible light spectrum. A first layer having a third adhesive strength of the above can be included. The sealing member can also include a second layer bonded to the first layer and a third layer detachably bonded to the second layer opposite the first layer. The third layer can be configured to block the passage of at least a portion of the electromagnetic radiation within the visible light spectrum. A force can be applied to the sealing member to shift the first layer from the first adhesive strength to the second adhesive strength and seal the sealing member to the mounting surface surrounding the tissue site. Negative pressure sources can be fluidly coupled to the tissue interface and negative pressure therapy can be performed. The third layer can be removed from the sealing member, and the first layer can shift from the second adhesive strength to the third adhesive strength in response to ambient light. The sealing member can then be removed.

The purpose, advantages, and preferred embodiments of creating and using the claimed subject matter can be best understood by reference to the accompanying drawings, along with the following detailed description of the exemplary embodiments.

FIG. 1 is a functional block diagram of an exemplary embodiment of a treatment system capable of providing negative pressure therapy or infusion therapy according to the present specification. FIG. 2 is a cross-sectional perspective view of a portion of the cover illustrating additional details that may be associated with the exemplary embodiments of the exemplary treatment system of FIG. FIG. 3 is a cross-sectional view of the cover of FIG. 2 illustrating additional details that may be associated with the use of the cover. FIG. 4 is a cross-sectional view of the cover of FIG. 2 from which the barrier layer has been removed. FIG. 5 is a cross-sectional view of another cover that may be used with the treatment system of FIG. FIG. 6 is a cross-sectional view of another cover that can be used with some embodiments of the treatment system of FIG. FIG. 7 is a cross-sectional view of another cover that can be used with some embodiments of the treatment system of FIG.

The following description of an exemplary embodiment provides information that allows one of ordinary skill in the art to create and use the subject matter described in the appended claims, but certain details already well known in the art. May be omitted. The detailed description below should therefore be construed as exemplary and not limiting.

Exemplary embodiments may also be described herein with reference to the spatial relationships between the various elements depicted in the accompanying drawings or the spatial orientation of the various elements. In general, such relationships or orientations are consistent with or a frame of reference for the patient in a position to receive treatment. However, as should be recognized by those skilled in the art, this frame of reference is not a strict rule, but merely a means of explanation.

FIG. 1 is a simplified functional block diagram of an exemplary embodiment of a treatment system 100 capable of providing negative pressure therapy with infusion of a topical treatment solution according to the present specification.

The term "tissue site" in this context includes, but is not limited to, on tissues including, but is not limited to, bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon or ligament. Or broadly refers to wounds, defects or other therapeutic targets located within the tissue. Wounds include, for example, chronic wounds, acute wounds, traumatic wounds, subacute wounds and dehiscence wounds, middle layer burns, ulcers (such as diabetic ulcers, compression ulcers or venous insufficiency ulcers), flaps and implants. But it may be. The term "tissue site" may also refer to any tissue area that is not necessarily damaged or missing, but rather an area where it may be desirable to assist or promote the growth of additional tissue. .. For example, negative pressure may be applied to the tissue site to grow additional tissue that can be harvested and transplanted.

The treatment system 100 may include a negative pressure source and may include or be configured to include or be coupled to a distribution component such as a dressing. In general, a partitioning component refers to any complementary or ancillary component configured to be fluidly coupled to a negative pressure source in the fluid path between the negative pressure source and the tissue site. There is. The distribution components are preferably removable and may be disposable, reusable, or reusable. For example, the dressing 102 may be fluidly coupled to the negative pressure source 104, as shown in FIG. The dressing may include, in some embodiments, a cover, a tissue interface, or both. The dressing 102 may include a cover 106 and a tissue interface 108. Also, a regulator or controller, such as the controller 110, may be coupled to the negative pressure source 104.

In some embodiments, the dressing interface 107 may facilitate binding of the negative pressure source 104 to the dressing 102. For example, such dressing interfaces are available from San Antonio, Texas, Kinetic Concepts Inc. ("KCI") available from T.I. R. A. C. (Registered Trademark) Pad or Senza T. et al. R. A. C. It may be a (registered trademark) pad. The treatment system 100 may optionally include a fluid container, such as a container 112, coupled to the dressing 102 and the negative pressure source 104.

The treatment system 100 may also include an infusion solution source. For example, the solution source 114 may be fluidly coupled to the dressing 102 as illustrated in the exemplary embodiment of FIG. The solution source 114 may be fluidly coupled to a positive pressure source such as the positive pressure source 116 or may be fluidly coupled to the negative pressure source 104 in some embodiments. A regulator such as the drip regulator 118 may also be fluidly coupled to the solution source 114 and the dressing 102. In some embodiments, the drip regulator 118 may also be fluidly coupled to the negative pressure source 104 through the dressing 102.

Additionally, the treatment system 100 may include a sensor for measuring the operating parameters and providing a feedback signal indicating the operating parameters to the controller 110. As illustrated in FIG. 1, for example, the treatment system 100 may include a pressure sensor 120, an electrical sensor 122, or both coupled to a controller 110. The pressure sensor 120 may also be coupled to or configured to be coupled to or coupled to the distribution component and the negative pressure source 104.

The components may be fluidly coupled to each other to provide a path for transferring fluids (ie, liquids and / or gases) between the components. For example, the components may be fluidly coupled through a fluid conduit such as a pipe. As used herein, a "tube" is a tube, pipe, hose, conduit, or other with one or more lumens adapted to carry fluid between two ends. Includes a wide range of structures. Usually, the tube is an elongated cylindrical structure with some flexibility, but the geometry and rigidity can vary. In some embodiments, the components may also be joined by physical proximity, either integrally with a single structure or formed from the same piece of material. Moreover, some fluid conduits may be molded within other components or otherwise combined integrally with other components. Bonds may also include mechanical, thermal, electrical or chemical bonds (such as chemical bonds) in some situations. For example, the tube may mechanically and fluidly bond the dressing 102 to the container 112.

In general, the components of the treatment system 100 may be directly or indirectly coupled. For example, the negative pressure source 104 may be directly coupled to the controller 110 and indirectly to the dressing 102 through the container 112.

Fluid dynamics using a negative pressure source to reduce pressure in another component or location, such as within a sealed treatment environment, can be mathematically complex. However, the basic principles of fluid mechanics applicable to negative pressure therapy and infusion are generally well known to those of skill in the art, and the steps of reducing pressure include, for example, "delivery", "distribution", or "generation" of negative pressure. May be exemplified herein.

In general, exudates and other fluids flow toward lower pressures along the fluid path. Therefore, the term "downstream" usually means a location in the fluid path that is relatively close to the negative pressure source or relatively far from the positive pressure source. Conversely, the term "upstream" usually means a location relatively far from the negative pressure source or relatively close to the positive pressure source. Similarly, it may be convenient to describe certain features with respect to the "inlet" or "outlet" of a fluid in such a frame of reference. This orientation is generally envisioned for the purposes of describing the various features and components herein. However, the fluid path may also be reversed in some applications (eg by using a positive pressure source instead of a negative pressure source), and the conventions in this description are construed as limited conventions. Should not be.

"Negative pressure" generally refers to a pressure lower than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment provided by the dressing 102. In many cases, the local ambient pressure may also be the atmospheric pressure at the location where the tissue site is located. Alternatively, the negative pressure may be lower than the tissue-related hydrostatic pressure at the tissue site. Unless otherwise indicated, the pressure values referred to herein are gauge pressures. Similarly, a reference to an increase in negative pressure usually refers to a decrease in absolute pressure, whereas a decrease in negative pressure usually refers to an increase in absolute pressure. The amount and nature of the negative pressure applied to the tissue site can vary depending on the treatment requirements, but the pressure is generally -5 mmHg (-667 Pa) to -500 mmHg (-66.7 kPa), also commonly referred to as coarse vacuum. Low vacuum. The general treatment range is -75 mmHg (-9.9 kPa) to -300 mmHg (-39.9 kPa).

The negative pressure source, such as the negative pressure source 104, may be a reservoir of negative pressure air, or, for example, a vacuum pump, a suction pump, a wall suction port available in many medical facilities, or a micro pump. It may be a manual or electric device capable of reducing the pressure in the sealed volume. Negative pressure sources may or may be housed within other components such as sensors, processing units, alarm indicators, memories, databases, software, display devices, or user interfaces that further facilitate treatment. May be used in conjunction with the components of. For example, the negative pressure source 104 may be combined with the controller 110 and other components to be a treatment unit. Negative pressure sources may also have one or more supply ports configured to facilitate coupling and disconnection of negative pressure sources to one or more distribution components. ..

The negative pressure source may include a controller, such as controller 110, or may be communicably coupled to the controller. The controller may be a microprocessor or computer programmed to operate one or more components of the treatment system 100, such as the negative pressure source 104. In some embodiments, for example, the controller 110 generally comprises an integrated circuit including a processor core and memory programmed to directly or indirectly control one or more operating parameters of the treatment system 100. It may be a microcontroller. The operating parameters may include the power applied to the negative pressure source 104, the pressure generated by the negative pressure source 104, or, for example, the pressure distributed to the tissue interface 108. The controller 110 is also preferably configured to receive one or more input signals, such as a feedback signal, and is programmed to modify one or more operating parameters based on the input signals.

A sensor, such as a pressure sensor 120 or an electrical sensor 122, is the art of operation as a device capable of detecting or measuring a physical phenomenon or characteristic and generally providing a signal indicating the detected or measured phenomenon or characteristic. Is generally known in. For example, the pressure sensor 120 and the electrical sensor 122 may be configured to measure one or more operating parameters of the treatment system 100. In some embodiments, the pressure sensor 120 may be a transducer configured to measure the pressure in the pneumatic path and convert the measured value into a signal indicating the measured pressure. In some embodiments, for example, the pressure sensor 120 may be a piezo resistance strain gauge. The electrical sensor 122 may optionally measure operating parameters of the negative pressure source 104, such as voltage or current, in some embodiments. Preferably, the signals from the pressure sensor 120 and the electrical sensor 122 are suitable as input signals to the controller 110, but in some embodiments some signal adjustment may be appropriate. For example, the signal may need to be filtered or amplified before it can be processed by the controller 110. Usually, the signal is an electrical signal, but it may be represented in other forms, such as an optical signal.

The positive pressure source, such as the positive pressure source 116, may be a reservoir of positive pressure air, or may be a manual or electric device capable of increasing the pressure within the sealed volume. The positive pressure source is housed or other in other components such as sensors, processing units, alarm indicators, memories, databases, software, display devices, or user interfaces that make treatment even easier. May be used in conjunction with components. For example, the positive pressure source 116 may be combined with a controller 110, a solution source 114, an infusion regulator 118, and other components to be a treatment unit. The positive pressure source may also have one or more supply ports configured to facilitate binding and disconnection of the positive pressure source to one or more distribution components.

The drip regulator, such as the drip regulator 118, may be a mechanical device or an electromechanical device configured to control the flow of fluid. The drip regulator can include a valve, microprocessor, or other component configured to control the positive pressure of the fluid into the sealed treatment environment.

The tissue interface 108 can be adapted to contact the tissue site. The tissue interface 108 may partially or wholly contact the tissue site. If the tissue site is a wound, for example, the tissue interface 108 may partially or completely occlude the wound, or may be arranged to cover the wound. The tissue interface 108 may take many forms and may have many sizes, shapes, or thicknesses depending on various factors such as the type of treatment to be given or the nature and size of the tissue site. You may. For example, the size and shape of the tissue interface 108 may be adapted to the contours of deep and irregularly shaped tissue sites. Moreover, any or all of the surfaces of the tissue interface 108 may have protrusions, or uneven, rough or jagged contours that can induce strain and stress in the tissue site. The protrusions or contours can promote granulation at the tissue site.

In some embodiments, the tissue interface 108 may be a manifold. A "manifold" in this context generally includes any substance or structure that provides multiple pathways adapted to collect or distribute fluid across tissue sites under pressure. For example, the manifold may be adapted to receive negative pressure from a negative pressure source and distribute the negative pressure over the tissue site through multiple openings, the manifold collecting fluid from the entire tissue site and the negative pressure source. It may have the effect of drawing the fluid toward. In some embodiments, the fluid pathway may be reversed or a secondary fluid pathway may be provided to facilitate delivery of the fluid over the tissue site.

In some exemplary embodiments, the manifold paths may be interconnected to improve fluid distribution or collection across tissue sites. In some exemplary embodiments, the manifold may be a porous foam material with interconnected bubbles or pores. For example, bubble foams, open cell foams, reticulated foams, porous tissue aggregates, and other porous materials such as gauze or felt mats are generally adapted to form interconnected fluid passages. Includes pores, edges, and / or walls. Liquids, gels and other foams may also be cured to include or include openings and fluid pathways. In some embodiments, the manifold may additionally or alternatively include protrusions that form interconnected fluid paths. For example, the manifold may be shaped to provide surface protrusions that define interconnected fluid paths.

The average pore size of the foam can vary depending on the needs of the given treatment. For example, in some embodiments, the tissue interface 108 may be a foam with a pore size in the range of about 400 to about 600 microns. The tensile strength of the tissue interface 108 may also vary depending on the needs of the given treatment. For example, the tensile strength of the foam may be increased for infusion of a topical treatment solution. In a non-limiting example, the tissue interface 108 is a reticulated polyurethane foam of open cells such as GranuFom® dressing or VeraFlo® foam, both available from KCI in San Antonio, Texas. You may.

The tissue interface 108 may be either hydrophobic or hydrophilic. In an example where the tissue interface 108 may be hydrophilic, the tissue interface 108 may also draw fluid from the tissue site while continuing to distribute negative pressure to the tissue site. The suction property of the tissue interface 108 can draw fluid from the tissue site by capillary flow or other suction mechanism. Examples of hydrophilic foams are from San Antonio, Texas, Kinetic Concepts, Inc. Available from V. A. C. It is an open cell foam made of polyvinyl alcohol such as WhiteFoam (registered trademark) dressing. Other hydrophilic foams may include those made from polyether. Other foams that may exhibit hydrophilic properties include hydrophobic foams that have been treated or coated to provide hydrophilicity.

The tissue interface 108 may further promote granulation at the tissue site when the pressure in the sealed treatment environment is reduced. For example, any or all of the surfaces of the tissue interface 108 may have an uneven, rough, or jagged outline that can induce microstrains and stresses in the tissue site when negative pressure is applied through the tissue interface 108. May have.

In some embodiments, the tissue interface 108 may be made from a bioreabsorptive material. Suitable bioreabsorbable materials may include, but are not limited to, a polymer blend of polylactic acid (PLA) and polyglycolic acid (PGA). Polymer blends may also include, but are not limited to, polycarbonate, polyfumarate, and coupler lactones. The tissue interface 108 may further serve as a scaffold for new cell proliferation, or the scaffold material may be used in conjunction with the tissue interface 108 to promote cell proliferation. A scaffold is generally a substance or structure used to promote or promote cell proliferation or tissue formation, such as a three-dimensional porous structure that provides a template for cell proliferation. Examples of scaffolding materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonates, or processed allogeneic implant materials.

Container 112 represents a container, canister, pouch or other storage component that can be used to control exudates and other fluids removed from tissue sites. In many environments, rigid containers may be preferred or required for fluid collection, storage, and disposal. In other environments, the fluid may be properly disposed of without storage in rigid containers, and reusable containers can reduce the waste and costs associated with negative pressure therapy.

The solution source 114 may also represent a container, canister, pouch, bag, or other storage component that can provide a solution for infusion therapy. The composition of the solution may vary depending on the given treatment, but examples of solutions that may be suitable for some formulations include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based. Examples include solutions, biguanides, cation solutions, and isotonic solutions.

In some embodiments, the cover 106 may provide a bacterial barrier and protection from physical trauma. The cover 106 may also be made of a material that can reduce evaporation loss and provide a fluid seal between the two components or between the two environments (such as between the therapeutic environment and the topical external environment). The cover 106 can include, for example, an elastomeric film or membrane that can provide a suitable seal to maintain negative pressure at the tissue site for a given negative pressure source. The cover 106 may have a high water vapor transmission rate (MVTR) in some applications. For example, the MVTR may be at least about 300 g / m ² per 24 hours. In some exemplary embodiments, the cover 106 may include a polymer drape, such as a polyurethane film, which is permeable to water vapor but impermeable to liquids. Such drapes typically have a thickness in the range of about 25 microns to about 50 microns. For permeable materials, the permeability should generally be low enough to maintain the desired negative pressure.

A mounting device may be used to mount the cover 106 on a mounting surface, such as an intact skin, gasket, or another cover. The mounting device may take many forms. For example, the mounting device may be a medically acceptable pressure sensitive adhesive that extends around the outer edge, portion, or whole of the sealing member. In some embodiments, some or all of the cover 106 may be coated with an acrylic adhesive having a coating weight of about 25 grams / square meter (gsm) to about 70 gsm. In some embodiments, thicker adhesives, or combinations of adhesives, may be applied to improve sealing and reduce leakage. For example, in some embodiments, the film layer may be coated with an acrylic adhesive having a coating weight of about 100 gsm to about 150 gsm. Other exemplary embodiments of the mounting device may include double-sided tape, glue, hydrophilic colloids, hydrogels, silicone gels, or organogels.

FIG. 2 is a cross-sectional perspective view of a portion of dressing 102 illustrating additional details that may be associated with some embodiments. The tissue interface 108 may be located within the tissue site 103, over the tissue site 103, or otherwise in close proximity to the tissue site 103. The cover 106 may be arranged so as to cover the tissue interface 108 and may be sealed to the mounting surface 105 in the vicinity of the tissue site 103. For example, the cover 106 may be sealed to an intact epidermis around the tissue site. Therefore, the dressing 102 can provide a hermetically sealed therapeutic environment in close proximity to the tissue site 103, substantially isolated from the external environment. The negative pressure source 104 can be fluidly coupled to the dressing 102 through the dressing interface 107 to reduce the pressure in the sealed treatment environment. Negative pressure applied over the tissue site 103 through the tissue interface 108 in a sealed treatment environment not only removes exudates and other fluids that can be collected in the vessel 112 from the tissue site 103, but also macrostrains and macrostrains to the tissue site 103. May induce microdistortion.

To ensure that the cover can maintain a sealed treatment environment over the tissue site, the mounting device may contain a high adhesive, high adhesive strength, or an adhesive having both high adhesiveness and high adhesive strength. .. A high adhesive strength adhesive is an adhesive that can easily adhere to the tissue and provide a seal between the cover and the tissue site. Viscosity refers to the properties of an adhesive that associates a particular adhesive strength of the adhesive on a substrate with the time required to achieve a particular adhesive strength.

In general, the cover can be difficult to handle when the user attempts to place the cover over a tissue site. Often, the cover needs to be sized and positioned to cover an area larger than the area of the tissue site to ensure a good seal for the sealed treatment environment. Due to the type and location of the tissue site and the surface area of the cover, the cover may be incorrectly attached to itself. For example, a portion of the cover may fold so that the adhesive on the cover contacts and adheres to itself. If the adhesive adheres to itself, it can be difficult to separate the adhesive surface of the adhesive without damaging the cover. In some cases, pulling the adhesive surface apart may form an irreparable crevice or create other cuts in the cover. As a result, the cover must be discarded as it may not provide and maintain a sealed therapeutic environment over the tissue site as desired.

Even if the cover is not mounted on itself when positioning the cover over the tissue site, the cover may be misattached to an undesired mounting surface or simply not properly positioned. If the cover is attached to an undesired mounting surface or is not properly positioned to form a sealed treatment environment over the tissue site, it is used to remove and reposition the cover without damaging it. It can be difficult for a person.

For tissue sites that may be located near or cover the curved portion of the patient, the user may have difficulty creating a seal between the cover and the mounting surface. To address such difficulties, the user may choose to cover the edges of the cover with another piece of cover or with approved tape. However, some high adhesives used for covers do not adhere well to the film used to form the cover, especially if the film material contains polyurethane.

Covers with high adhesive strength adhesives can also be difficult to remove during or after treatment. Adhesives that are strong enough to adhere to the tissue during negative pressure or infusion therapy can often cause pain and tissue damage to the patient during removal. Many negative pressure or IV regimens may require the cover to be removed and replaced during treatment, which can cause the cover to wear or be damaged and cause the patient to feel more pain than necessary. Sometimes.

In addition, many high adhesive strength adhesives lose their viscosity when exposed to moisture, such as sweat from the patient's body on the mounting surface. As a result, if the patient sweats and results in a leak, the cover that originally held the seal may lose contact with the mounting surface. Similarly, some high adhesive strength adhesives used for covers can lose their viscosity in the presence of body heat. Again, if the patient's body temperature warms the adhesive, resulting in leakage, the cover that originally held the seal may lose contact with the mounting surface.

The cover 106 of the treatment system 100 has those problems and other problems by providing a cover with an adhesive having a first adhesive strength that holds the cover over the tissue site 103 while the cover 106 is positioned. The problem can be addressed and removed without damaging the mounting surface 105 or other tissue. The adhesive on the cover 106 can also attach the cover 106 to the mounting surface 105 on the tissue site 103 to form a sealed treatment environment and prevent negative pressure and leakage of other fluids from the sealed treatment environment. It may have adhesive strength. The adhesive on the cover 106 may also have a third adhesive strength that allows the cover 106 to be removed from the tissue site 103 while minimizing pain or other trauma to the patient. In an exemplary embodiment, the cover 106 may have a first layer or mounting layer, such as an adhesive layer 124, a second layer or backing layer, such as a film layer 126, and a third layer, such as a barrier layer 128. Alternatively, it may include a filter layer.

The adhesive layer 124 may be an acrylic adhesive, a polyurethane adhesive, a hydrophilic colloid, a hydrogel, a silicone gel, or an organogel. The adhesive layer 124 may also be pressure sensitive. A pressure-sensitive adhesive is an adhesive that has increased adhesive strength when pressure is applied to the adhesive. The increase in the adhesive strength of the pressure sensitive adhesive may be caused by cross-linking. Crosslinking occurs by chemically linking two or more molecules with a covalent bond that connects one polymer chain to another. The adhesive strength of the adhesive increases as the crosslinks increase until the adhesive reaches the maximum adhesive strength. Further cross-linking may degrade the adhesive strength of the adhesive. The curve plotting the adhesive strength vs. the amount of cross-linking of the adhesive, where the adhesive strength is on the y-axis and the amount of cross-linking is on the x-axis, is generally well understood by those skilled in the art. As shown in the figure, it occurs at the midpoint of the curve along the x-axis.

When a force is applied to the pressure sensitive adhesive, the force may increase cross-linking, thereby increasing the adhesive strength of the adhesive. In some exemplary embodiments, the pressure sensitive adhesive may also be a fluid adhesive or a gap-filling adhesive, the adhesive being sufficiently viscous to stay on the substrate and covering. It is also non-viscous enough to close any gaps or leaks that may occur between the 106 and the mounting surface 105. When a force is applied directly or indirectly to a pressure sensitive or fluid adhesive, the applied force is applied to the adhesive to better close the crevices and gaps between the mounting surface 105 and the cover 106. The viscosity can be reduced. In some embodiments, cross-linking can be controlled during application of the adhesive in order to enhance the fluidity properties of the adhesive and increase the adhesive strength to the maximum adhesive strength value. Cross-linking can be controlled by including a cross-linking agent that can be encapsulated and reacts to the expected force applied to the adhesive.

In some exemplary embodiments, the adhesive layer 124 may be an acrylic adhesive having a coating weight in the range of about 15 g / m ² (gsm) to about 70 gsm. The adhesive layer 124 may have a thickness in the range of about 30 microns to about 70 microns. In another exemplary embodiment, the adhesive layer 124 may have a thickness in the range of about 100 microns to about 150 microns. In some exemplary embodiments, increasing the thickness of the adhesive layer 124 may provide additional adhesive to flow into the crevice between the cover 106 and the mounting surface 105. Additional adhesives can close the crevice to increase the tightness of the sealing treatment environment and reduce negative pressure and leakage of other fluids through the interface between the cover 106 and the mounting surface 105. ..

The adhesive strength of the adhesive material may be measured with respect to the force required to remove the adhesive from the substrate. The force required to remove the adhesive from the substrate can also be referred to as delamination adhesive force or delamination resistance. The American Society for Testing and Materials (ASTM) has standardized the peeling adhesive force as the force required to remove the adhesive from the stainless steel substrate at 23 ° C. and 50% relative humidity based on ASTM D3330. The viscosity or tackiness of the adhesive material may be measured by the time it takes for the adhesive to reach the desired adhesive strength. For example, high viscosity means that the adhesive strength increases to the desired adhesive strength in a relatively short time. In one exemplary embodiment, the adhesive layer 124 may have a first adhesive strength in the range of about 0.5 N / 25 mm to about 1.5 N / 25 mm. In some exemplary embodiments, the adhesive layer 124 may have low to moderate adhesiveness to which the adhesive layer 124 may achieve a first adhesive strength after a contact time of less than 60 seconds. good.

In some embodiments, the adhesive layer 124 may be a pressure sensitive adhesive with increased adhesive strength when pressure is applied to the adhesive layer. As a result, the adhesive strength of the adhesive layer 124 may shift from a first adhesive strength to a second adhesive strength when pressure or force is applied directly or indirectly to the adhesive layer 124. In some exemplary embodiments, the second bond strength may be greater than the first bond strength. For example, the second adhesive strength may have a peeling adhesive force or peeling resistance in the range of about 6N / 25mm to about 10N / 25mm.

In some embodiments, a tackifier, a low surface tension additive, an adhesive softener, or other cross-linking agent may be placed in the adhesive layer 124. The tackifier may increase the stickiness of the adhesive layer 124 when activated. The low surface tension additive may increase the fluidity of the adhesive layer 124 when activated. In some embodiments, the pressure applied directly or indirectly to the outside of the adhesive layer 124 can elicit the reaction of the tackifier, low surface tension additive, or other cross-linking agent. Activation of a tackifier, low surface tension additive, or other cross-linking agent in the adhesive layer 124 increases cross-linking, making the adhesive layer 124 from a first bond strength to a second bond strength. It can help with the transition.

In some embodiments, tackifiers, low surface tension additives, or other cross-linking agents may be contained in the microcapsules. Direct or indirect pressure or force exerted on the outside of the adhesive layer 124 may cause the microcapsules to rupture and release the additive to interact with the adhesive on the adhesive layer 124. In some embodiments, the release from the microcapsules may cause the additive to react locally to create a viscous site on the interface of the adhesive layer 124. In other embodiments, the adhesive strength of the adhesive layer 124 may be increased by chemical means by releasing the active agent into the adhesive layer 124.

The adhesive layer 124 may also be a convertible adhesive. A convertible adhesive is an adhesive that can have high adhesive strength during the use of the adhesive, but can be selected or converted to reduce the adhesive strength when the adhesive is no longer needed. .. One way the adhesive can be converted is by the use of crosslinks. For example, when the adhesive is crosslinked to the maximum adhesive strength of the adhesive, for example from the first adhesive strength to the second adhesive strength, the adhesive is further added so that the cover becomes brittle to assist in the removal of the cover. It may be crosslinked. Optionally, the adhesive may be further crosslinked by the use of a conversion source. The conversion source may be, for example, a liquid solution, an inert gas, or an electromagnetic radiation source. Alternatively, in other embodiments, electromagnetic radiation, such as visible light or ultraviolet light, may be used to increase the cross-linking of the adhesive beyond the maximum adhesive strength of the adhesive.

In some exemplary embodiments, the adhesive layer 124 may comprise a photoinitiator or photosensitive agent. The photosensitive agent may be a compound disposed in an adhesive layer 124 that reacts to electromagnetic radiation of one or more wavelengths or a range of wavelengths. For example, the adhesive layer 124 may contain a photosensitive agent configured to react to light in a purple, indigo, or blue spectrum (blue spectrum). The blue spectrum may include electromagnetic radiation having wavelengths consistent with the purple, indigo, and blue wavelengths of about 380 nm to about 495 nm, preferably about 470 nm. Upon exposure to the blue spectrum, the emulsion can be activated and react with the adhesive layer 124. The reaction between the photosensitizer and the adhesive layer 124 proceeds with cross-linking, thereby shifting the adhesive strength of the adhesive layer 124 from the second adhesive strength to the third adhesive strength. In some embodiments, the third adhesive strength may be about 50% of the second adhesive strength.

Examples of non-limiting examples of emulsions include camphorquinones such as Rahn AG's Genocure® CQ, and Spectra Group Limited, Inc. 5,7-Diiodot-3-butoxy-6-fluoroene, such as H-NU470, may be mentioned. Typical photosensitive agents are fully cured by long wavelength electromagnetic radiation and are soluble in alcohols, ketones, acrylates and methacrylates. A representative photosensitive agent may also have a molecular weight of 520 g / mol, a melting point of> 270 ° C., a maximum wavelength absorbance of about 470 nm, and a molar extinction coefficient of 30,200. More generally, the photosensitizer has a panchromatic absorbance of electromagnetic radiation having wavelengths in the ultraviolet and visible light spectra, particularly in the wavelength range of 350 nm to 670 nm. In some embodiments, the photosensitive agent can cure the acrylate and epoxide. Suitable emulsions can have high absorbency of electromagnetic radiation and may be used at low solution concentrations. For example, the suitable concentration of the photosensitive agent in the adhesive solution may be about 0.1 to 0.15% of the adhesive solution. Typical emulsions can be cured through a material larger than 1 inch, and in some embodiments cured through an ultraviolet, opaque, pigmented or colored substrate. And can change color after curing.

Room lighting produces electromagnetic radiation that covers the visible light spectrum and generally contains a wavelength of 450 nm. Interior lighting can include halogen lamps, incandescent lamps, metal halide lamps, sodium lamps, and fluorescent lamps. In some embodiments, the peak sensitivity of the photosensitive agent may be at a wavelength of about 450 nm. Therefore, indoor lighting within the 450 nm wavelength can activate the photosensitive agent and crosslink the adhesive layer 124 to shift from a second adhesive strength to a third adhesive strength within at least 10 minutes. In another exemplary embodiment, when the adhesive layer 124 is exposed to natural light, the adhesive layer is less than 10 minutes, eg, in the range of about 3 to about 6 minutes, due to the cross-linking caused by the photosensitizer. The 124 can be transferred from the second adhesive strength to the third adhesive strength.

In a non-limiting example, the adhesive layer 124 may include a convertible adhesive such as Adhesive Adhesive available from Lumina Adhesives AB located in Varbergsgatan 2A, 412 65 Goeteborg, Sweden. The adhesive layer 124 containing the Adhesive adhesive may be configured to convert in response to exposure to electromagnetic radiation. In some exemplary embodiments, the adhesive layer 124 containing the Adheright adhesive has a second adhesive strength of about 35 N / 25 mm prior to exposure to electromagnetic radiation of a particular wavelength and electromagnetic radiation of a particular wavelength. It has a third adhesive strength of about 4N / 25mm after exposure to. In another exemplary embodiment, the adhesive layer 124 containing the Adheright adhesive may have a second adhesive strength of about 2.5 N / 25 mm and after exposure to electromagnetic radiation of a particular wavelength. It can be reduced to a third adhesive strength of about 0.5 N / 25 mm.

The film layer 126 may be a water vapor moisture permeable film. For example, the film layer 126 may have a water vapor transmission rate (MVTR) of about 15,000 to 16,000 g / m ^2/24 hours tested using the inversion cup technique. Using upright cup technology, the film layer 126 may have an MVTR of about 3,000 to about 4,000 g / m ^2/24 hours. The tensile strength of the film layer 126 may be in the range of about 800 g / 25 mm to about 1200 g / 25 mm and may have an elongation of about 400% to 440%. In some embodiments, the film layer 126 may be transparent. In other embodiments, the film layer 126 may be translucent. The film layer 126 may be made of polyurethane and have a thickness of about 15 microns. In some embodiments, the film layer 126 may be substantially impermeable to liquid. In a non-limiting example, the film layer 126 may be Inspire® 2151 from Coveris Advanced Coatings. In some embodiments, the film layer 126 may comprise carboxymethyl cellulose (CMC). CMC is a cellulose derivative that can be in close proximity to the film layer 126 or, in the case of water vapor, can absorb liquids that can penetrate the film layer 126. In some embodiments, sodium and potassium can easily interact with CMC.

The barrier layer 128 may be a water vapor moisture permeable film. In some embodiments, the barrier layer 128 may be formed from polyurethane, polyamide, polyether blockamide (PEBA), ethylene-vinyl acetate (EVA), polyvinyl alcohol, or hydroxy or carboxy-modified acrylics. The barrier layer 128 may have a high MVTR. For example, the barrier layer 128 may have an MVTR tested using the inversion cup technique at about 15,000 to 16,000 g / m ^2/24 hours. Using upright cup technology, the barrier layer 128 may have an MVTR of about 3,000 to about 4,000 g / m ^2/24 hours. The tensile strength of the barrier layer 128 may be in the range of about 800 g / 25 mm to about 1,200 g / 25 mm and may have an elongation rate of about 400% to 440%. In some embodiments, the barrier layer 128 may be transparent. In other embodiments, the barrier layer 128 may be translucent. The barrier layer 128 may be made of polyurethane and have a thickness of about 15 microns. The barrier layer 128 may be liquid impermeable. In a non-limiting example, the barrier layer 128 may be Inspire® 2151 from Coveris Advanced Coatings.

In some embodiments, the barrier layer 128 may be colored, dyed, or tinted. The dye or colorant can be added during the manufacturing process of the barrier layer 128 to allow the barrier layer 128 to transmit only light having a wavelength visible as the color of the dye or colorant. Other electromagnetic radiation is absorbed by colorants or dyes. The barrier layer 128 may remain substantially transparent after the dyeing step. In some embodiments, the barrier layer 128 may be shaded with a yellow dye or colorant. The yellow colorant may transmit electromagnetic radiation having a wavelength of about 570 nm to about 620 nm and filter or block other electromagnetic radiation wavelengths. In other embodiments, the barrier layer 128 may be stained, tinted, or colored so that the barrier layer 128 can transmit different wavelengths of the electromagnetic radiation spectrum.

The cover 106 may be made by providing the film layer 126 and coating the first side surface of the film layer 126 with an adhesive to form the adhesive layer 124. Additives, such as microcapsules, tackifiers, low surface tension additives, or photosensitizers, may be placed in the adhesive prior to coating the film layer 126. The adhesive layer 124 may be cured or dried, and the barrier layer 128 can be adhered to the second side surface of the film layer 126 opposite the adhesive layer 124. Prior to adhesion of the barrier layer 128 to the film layer 126, the barrier layer 128 may be dyed or colored. In other embodiments, the adhesive layer 124 may be patterned, molded, or otherwise formed on the film layer 126.

FIG. 3 is a cross-sectional view of a portion of the cover 106 positioned on the mounting surface 105 and illustrates additional details that may be associated with some embodiments. The cover 106 may be positioned above the tissue site so that a portion of the surface of the adhesive layer 124 opposite the film layer 126 is in contact with the mounting surface 105. In some embodiments, the first adhesive strength of the adhesive layer 124 may hold the cover 106 in place, but the cover 106 does not irritate and / or damage the mounting surface 105 and / or to the patient. Allows removal from the mounting surface 105 without causing pain. To shift the adhesive layer 124 from a first adhesive strength to a second adhesive strength when the cover 106 is suitably positioned such that the adhesive layer 124 is positioned to provide sufficient sealing. A force F may be applied to the barrier layer 128. For example, the user may apply pressure or force F directly to the barrier layer 128 by hand or finger. In some embodiments, the user may apply force F to the barrier layer 128 against selected areas of cover 106. For example, the user may apply a force F to the cover 106 that covers the mounting surface 105. In other embodiments, the user may apply force F substantially over the entire cover 106. For example, the user may apply force to the portion of the cover 106 that covers the mounting surface 105, the tissue site 103, and the tissue interface 108. The force F may cause cross-linking of the adhesive layer 124 that shifts the adhesive layer 124 from the first adhesive strength to the second adhesive strength. The force F may also increase the flow of the adhesive layer 124 to other locations where there may be cracks or leaks between the cover 106 and the mounting surface 105. In some embodiments, the second adhesive strength of the adhesive layer 124 anchors the cover 106 onto the tissue site 103 to prevent the cover 106 from being accidentally removed from the mounting surface 105 during treatment. Therefore, it may be higher than the first adhesive strength.

In some embodiments, the barrier layer 128 is selected to filter some electromagnetic radiation, more specifically, some electromagnetic radiation within the visible light spectrum so that it does not pass through the barrier layer 128. May be good. By filtering some of the electromagnetic radiation within the visible light spectrum, the barrier layer 128 can prevent the filtered electromagnetic radiation from prematurely activating the adhesive layer 124. As shown in FIG. 3, the barrier layer 128 absorbs electromagnetic radiation having a wavelength of about 400 nm to about 475 nm, that is, blue-purple light 136 to prevent the blue-purple light 136 from passing through the barrier layer 128. It may be selected. By preventing the bluish-purple light 136 from penetrating the barrier layer 128 and reaching the adhesive layer 124, the barrier layer 128 prevents activation of the photosensitive agent disposed in the adhesive layer 124. As a result, the adhesive layer 124 may maintain a second adhesive strength to ensure that the cover 106 is not accidentally removed.

In another embodiment, the barrier layer 128 is for transmitting electromagnetic radiation and other wavelengths, such as wavelengths from about 570 nm to about 750 nm, more specifically wavelengths from 570 nm to about 590 nm, i.e. visible light 134. May be selected for. Much of the visible light 134 is transmitted through the barrier layer 128 and the adhesive layer 124 and then reflected by the mounting surface 105, the tissue site 103, and / or the tissue interface 108, followed by the adhesive layer 124 and the barrier layer 128. It passes back through, which makes the barrier layer 128 appear yellow. Although the barrier layer 128 appears yellow in color, the reflected visible light 134 still provides an image that allows the user to continue to monitor the tissue site as seen through the cover 106 during application of treatment.

FIG. 4 is a cross-sectional view of cover 106 illustrating additional details that may be associated with some embodiments. If the cover 106 is removed from the mounting surface 105, the barrier layer 128 may be removed from the film layer 126. By removing the barrier layer 128, filtering of electromagnetic radiation can be stopped. After removal of the barrier layer 128, electromagnetic radiation containing both blue-violet light 136 and visible light 134 can propagate through the film layer 126 to reach the adhesive layer 124. When the adhesive layer 124 contains a photosensitive agent, the photosensitive agent in the adhesive layer 124 may be activated by blue-purple light 136. When the photosensitive agent is activated by blue-violet light 136, the adhesive layer 124 is further crosslinked. Cross-linking of the adhesive layer 124 may shift the adhesive layer 124 to a strength exceeding the maximum adhesive strength of the adhesive layer 124. As a result, the adhesive layer 124 may shift from the second adhesive strength to the third adhesive strength. In some embodiments, the third adhesive strength is lower than the second adhesive strength, facilitating the separation and removal of the adhesive layer 124 from the mounting surface 105.

In some embodiments, the barrier layer 128 does not have to be shaded or colored, allowing the barrier layer 128 to be transparent and clear. The photosensitive agent added to the adhesive layer 124 can react to ultraviolet rays, that is, electromagnetic radiation having a wavelength of about 10 nm to about 125 nm. The barrier layer 128 may contain a chromophore or other light-absorbing group, such as ClearSheld by Milliken or Solarsorb by Croda. The chromophore may absorb electromagnetic radiation having a wavelength of up to 390 nm. The chromophore allows the barrier layer 128 to block UV light from passing through the barrier layer 128 while maintaining the transparency and clarity of the cover layer 106. In some embodiments, the ultraviolet light source that radiates ultraviolet light may be provided with a cover 106. When the barrier layer 128 is removed, an ultraviolet light source may be used to induce a transition from a second adhesive strength to a third adhesive strength of the adhesive layer 124. The transition from the second adhesive strength to the third adhesive strength of the adhesive layer 124 can facilitate the separation and removal of the adhesive layer 124 from the mounting surface 105.

In some other exemplary embodiments, the barrier layer 128 may include a fluorescent dye, a fluorescent agent, or a fluorescent print. The barrier layer 128 may fluoresce with an additive in response to exposure to light having a particular wavelength, such as 450 nm. The fluorescent agent can, for example, give the user an indication that the barrier layer 128 has not been removed.

FIG. 5 is a cross-sectional view of another embodiment of cover 106 illustrating additional details that may be associated with some embodiments. The cover 106 may include a release layer 130 and a support layer or a carrier layer 132. The release layer 130 may be a silicone-treated paper layer bonded to the surface of the adhesive layer 124 on the opposite side of the film layer 126. The release layer 130 may be configured to protect the adhesive layer 124 prior to use of the cover 106, especially during shipping and storage of the cover 106. The release layer 130 may be removed prior to use of the cover 106. The carrier layer 132 may be a silicone-treated paper layer or another film layer. The carrier layer 132 may be bonded to the surface of the barrier layer 128 opposite the film layer 126. The carrier layer 132 may protect the barrier layer 128 prior to use of the cover 106 and may be removed prior to use of the cover 106.

FIG. 6 is a cross-sectional view of another embodiment of the cover 106, illustrating additional details that may be used with some embodiments. The cover 106 may include an adhesive layer 124 bonded to the first side surface of the film layer 126 and a barrier layer bonded to the second side surface of the film layer 126. The cover 106 further includes a release layer 130 bonded to the side surface of the adhesive layer 124 opposite the film layer 126 and a carrier layer 132 bonded to the side surface of the barrier layer 128 opposite the film layer 126. Can be done.

In some embodiments, the adhesive layer 124 may include a plurality of microcapsules 138. Microcapsules 138 can be formed from synthetic polymers such as aminoplasts or natural polymers such as gelatin. The microcapsules 138 may be filled with ink or dye. In some embodiments, the microcapsules 138 may contain a green dye, but the color of the particular dye is not required. In some embodiments, the microcapsules 138 may be ruptured by force F to release the ink or dye. The ink or dye may stain the adhesive on the adhesive layer 124 to give a visual indication that force F is being applied to the adhesive layer 124. In some embodiments, the microcapsules 138 have an adhesive layer 124 such that the force F applied to the adhesive layer 124 substantially shifts the adhesive layer 124 from a first adhesive strength to a second adhesive strength. May be configured to burst if the force F required to bridge the is.

The adhesive layer 124 may also contain a plurality of microcapsules 140. The microcapsules 140 may be formed from a synthetic polymer such as aminoplast or a natural polymer such as gelatin. The microcapsules 140 may have a photosensitive agent placed within the material of the microcapsules 140. The microcapsules 140 may be filled with ink or dye. In some embodiments, the microcapsules 140 may contain a red dye, but the color of the particular dye is not required. The photosensitive agent placed in the material forming the microcapsules 140 may be activated by exposure to blue-violet light 136 to rupture the microcapsules 140. In some embodiments, the microcapsules 140 burst after exposure to blue-violet light 136 for approximately the same amount of time required to transition the adhesive layer 124 from the second adhesive strength to the third adhesive strength. It may be configured to do so. If the microcapsules 140 burst in response to exposure to blue-violet light 136, the ink or dye is released to give the user an indication that the cover 106 is ready to be removed.

In some embodiments, the adhesive layer 124 may contain a fluorescent additive. The fluorescent additive may be configured to fluoresce in the presence of bluish-purple light 136, providing an indicator that the barrier layer 128 has been removed from the cover 106. In some embodiments, the fluorescent additive may be similar to the UltraRed TM provided by Dymax®.

FIG. 7 is a cross-sectional view of another cover 106 illustrating additional details that may be associated with some embodiments. The cover 106 may include an adhesive layer 124 bonded to the first side surface of the film layer 126 and a barrier layer bonded to the second side surface of the film layer 126. The cover 106 further includes a release layer 130 bonded to the side surface of the adhesive layer 124 opposite the film layer 126 and a carrier layer 132 bonded to the side surface of the barrier layer 128 opposite the film layer 126. Can be done. The cover 106 can also include microcapsules 138 and microcapsules 140. The microcapsules 138 and 140 may be placed on the surface of the adhesive layer 124 adjacent to the film layer 126. The color indication given by the microcapsules 138 and 140 when ruptured may be visible to the user on the surface of the adhesive layer 124 in contact with the film layer 126.

The systems, equipment, and methods described herein can provide significant advantages. For example, the covers described herein provide a less leaky cover for negative pressure therapy while providing less traumatic removal for the patient. The covers described can be easily applied and can be repositioned before the final seal is obtained. The provided cover can also seal areas that are difficult to seal. For example, body contours, joints, and wound environments that may be located around the body can be covered and sealed with the covers described herein. Intravenous therapy, negative pressure therapy and positive pressure therapy can all be performed using the exemplary cover. The cover described may also provide a visual clue as to the condition of the drape as it prepares for sealing and removal.

As shown in a few exemplary embodiments, one of ordinary skill in the art will recognize that the systems, equipment and methods described herein have room for acceptance of various changes and modifications. .. Moreover, explanations of various alternatives using terms such as "or" need not be mutually exclusive unless explicitly required by the context, and the indefinite article "one (a)" or "one". (An) ”is not limited to a single example unless explicitly required by the context.

The components may also be combined or excluded in various configurations for sale, manufacture, assembly, or use. For example, in some configurations, the dressing 102, the container 112, or both may be excluded or separated from other components for manufacture or sale. In other exemplary configurations, the controller 110 may also be manufactured, configured, assembled, or sold independently of other components.

Although the appended claims describe new and progressive aspects of the subject matter described above, the claims may also include additional subject matter not specifically detailed. good. For example, certain features, elements, or embodiments may be omitted from the claims to distinguish between new and progressive features and those already known to those of skill in the art. .. Also, alternatives in which the features, elements, and embodiments described herein serve the same, equivalent, or similar purpose without departing from the scope of the invention as defined by the appended claims. It may be combined with or replaced with these alternative features.

Claims (64)

In a drape for medical use, a film layer in which the drape has a first side surface and a second side surface,
An adhesive layer bonded to the first side surface of the film layer, which is a pressure-sensitive adhesive configured to cross the adhesive layer and a photosensitive agent configured to cross the adhesive layer. The first adhesive strength before the application of the drape, the second adhesive strength larger than the first adhesive strength in response to the force applied to the drape, and the electromagnetic wave in the visible light spectrum. The adhesive layer having a third adhesive strength that is less than the second adhesive strength after exposure of the adhesive layer to radiation.
A drape comprising a barrier layer that is detachably coupled to the second side surface of the film layer and is configured to block at least a portion of the electromagnetic radiation within the visible light spectrum. The drape according to claim 1, wherein the adhesive layer contains an acrylic adhesive. The drape according to claim 1, wherein the adhesive layer contains a polyurethane-based adhesive. The drape according to claim 1, wherein the adhesive layer contains a fluid adhesive. The drape according to claim 1, wherein the adhesive layer contains a gap-filling adhesive. The drape according to claim 1, wherein the adhesive layer contains a pressure-sensitive adhesive. The drape according to claim 1, wherein the force changes the viscosity and flow of the adhesive layer. The drape according to claim 1 further comprises an activator disposed in the adhesive layer, and in response to the force, the activator attaches the adhesive layer to the first adhesive strength. A drape characterized in that it is configured to shift to the adhesive strength of 2. The drape according to claim 1, further comprising a tackifier arranged in the adhesive layer. The drape according to claim 1, further comprising a low surface tension additive disposed in the adhesive layer. In the drape according to claim 1, the microcapsules arranged in the adhesive layer contain the tackifier and burst in response to the force to release the tackifier. A drape characterized by further comprising the microcapsules configured in. In the drape according to claim 1, the microcapsules arranged in the adhesive layer contain an adhesive softener and burst in response to the force to release the adhesive softener. A drape characterized by further comprising said microcapsules configured as such. In the drape according to claim 1, the microcapsules arranged in the adhesive layer are configured to contain a dye and burst in response to the force to release the dye. A drape characterized by further containing microcapsules. In the drape according to any one of claims 11 to 13, the microcapsules are formed from a material selected from the group consisting of one or more of synthetic polymers, aminoplasts, natural polymers, and gelatin. A drape characterized by that. The drape according to claim 1, wherein the third adhesive strength is about 50% of the second adhesive strength. In the drape according to claim 1,
The third adhesive strength is about 50% of the second adhesive strength, and a plurality of microcapsules encapsulating the dye are arranged in the adhesive layer and electromagnetic radiation in the visible light spectrum. A drape characterized by being configured to burst in response to exposure to. In the drape according to claim 1,
The third adhesive strength is about 50% of the second adhesive strength, and the adhesive layer is configured to contain a fluorescent dye and fluoresce in response to exposure to the electromagnetic radiation. ,
A drape characterized by that. In the drape according to claim 1, the visible light spectrum comprises electromagnetic radiation having a wavelength of about 430 nanometers to about 470 nanometers, and one or more photosensitizers are disposed in the adhesive layer. The drape is characterized in that the photosensitizer is configured to react to electromagnetic radiation having a wavelength of about 430 nanometers to about 470 nanometers. The drape according to claim 1, wherein the photosensitive agent is selected from the group consisting of camphorquinone and 5,7-diiodot-3-butoxy-6-fluoroene. The drape according to claim 1, wherein the film layer includes a polyurethane film layer. The drape according to claim 20, further comprising carboxymethyl cellulose (CMC) disposed in the film layer. The drape according to claim 21, wherein the film layer is configured to absorb a liquid. The drape according to claim 1, wherein the barrier layer includes a polyurethane film layer. The drape according to claim 1, wherein the barrier layer has a yellow tint. The drape according to claim 1, wherein the barrier layer contains a polyurethane film having a yellow tint. The drape according to claim 1, wherein the barrier layer is substantially transparent. The drape according to claim 1, wherein the barrier layer contains a substantially transparent polyurethane film having a yellow tint. The drape according to claim 1, further comprising a chromophore arranged in the barrier layer. The drape according to claim 1, further comprising an electromagnetic radiation absorbing group arranged in the barrier layer. In the drape according to claim 1, the barrier layer is made of one or more of highly breathable polymers, polyurethanes, polyamides, polyether blockamides, ethylene-vinyl acetate, polyvinyl alcohol, hydroxyacrylics, and carboxyacrylics. A drape characterized by containing materials selected from the group consisting of. The drape according to claim 1, further comprising a peeling layer detachably bonded to the adhesive layer on the opposite side of the film layer. The drape according to claim 1, further comprising a support layer detachably bonded to the barrier layer on the opposite side of the film layer. In the drape according to claim 1,
A peeling layer releasably bonded to the adhesive layer on the opposite side of the film layer,
A support layer detachably bonded to the barrier layer on the opposite side of the film layer,
A drape characterized by being equipped with. In a system for providing negative pressure therapy, the system is:
With a manifold configured to be positioned above the tissue site,
A drape that is positioned on the manifold and configured to be sealed to a mounting surface that surrounds the tissue site.
A backing layer having a first side surface and a second side surface,
A mounting layer coated on the first side surface of the backing layer, the tackifier configured to crosslink the mounting layer and a photosensitive agent configured to crosslink the mounting layer. To the first adhesive strength before the application of the drape, the second adhesive strength larger than the first adhesive strength in response to the force applied to the drape, and the electromagnetic radiation in the visible light spectrum. With the mounting layer having a third adhesive strength that is less than the second adhesive strength after exposure of the mounting layer.
The drape, which comprises a filter layer that is detachably coupled to the second side surface of the backing layer and is configured to block at least a portion of the electromagnetic radiation in the visible light spectrum.
A system comprising a negative pressure source configured to be fluidly coupled to the manifold. The system according to claim 34, wherein the mounting layer contains an acrylic adhesive. The system according to claim 34, wherein the mounting layer contains a polyurethane-based adhesive. The system according to claim 34, wherein the mounting layer comprises a fluid adhesive. The system according to claim 34, wherein the mounting layer contains a gap filling adhesive. The system according to claim 34, wherein the mounting layer contains a pressure sensitive adhesive. The system according to claim 34, wherein the force changes the viscosity and flow of the mounting layer. The system according to claim 34, further comprising a low surface tension additive disposed in the mounting layer. In the system according to claim 34, the microcapsules arranged in the mounting layer contain the tackifier and burst in response to the force to release the tackifier. A system comprising further comprising said microcapsules to be configured. In the system of claim 34, the microcapsules disposed in the mounting layer contain an adhesive softener and burst in response to the force to release the adhesive softener. A system comprising the microcapsules further comprising the microcapsules. In the system of claim 34, the microcapsules disposed in the mounting layer, the microcapsules that contain a dye and are configured to burst in response to the force to release the dye. A system characterized by further inclusion of capsules. In the system of any one of claims 42-44, the microcapsules are formed from a material selected from the group consisting of one or more of synthetic polymers, aminoplasts, natural polymers, and gelatin. A system characterized by that. The system according to claim 34, wherein the third adhesive strength is about 50% of the second adhesive strength. In the system of claim 34.
The third adhesive strength is about 50% of the second adhesive strength, and
A plurality of dye-encapsulated microcapsules are placed in the mounting layer and configured to burst in response to exposure to electromagnetic radiation within the visible light spectrum.
A system characterized by that. In the system of claim 34.
The third adhesive strength is about 50% of the second adhesive strength, and
The mounting layer contains a fluorescent dye and is configured to fluoresce in response to exposure to the electromagnetic radiation.
A system characterized by that. In the system of claim 34, the visible light spectrum comprises electromagnetic radiation having a wavelength of about 430 nanometers to about 470 nanometers, and one or more photosensitizers are placed in the mounting layer. A system characterized in that the photosensitizer is configured to react to electromagnetic radiation having a wavelength of about 430 nanometers to about 470 nanometers. The system according to claim 34, wherein the photosensitive agent is selected from the group consisting of camphorquinone and 5,7-diiodot-3-butoxy-6-fluoroene. The system according to claim 34, wherein the backing layer includes a backing layer of polyurethane. The system according to claim 51, further comprising carboxymethyl cellulose (CMC) disposed in the backing layer. The system according to claim 52, wherein the backing layer is configured to absorb a liquid. The system according to claim 34, wherein the filter layer includes a backing layer of polyurethane. The system according to claim 34, wherein the filter layer has a yellow tint. The system according to claim 34, wherein the filter layer contains a polyurethane film having a yellow tint. The system according to claim 34, wherein the filter layer is substantially transparent. The system according to claim 34, wherein the filter layer comprises a substantially transparent polyurethane film having a yellow tint. The system according to claim 34, further comprising a chromophore disposed in the filter layer. The system according to claim 34, further comprising an electromagnetic radiation absorbing group arranged in the filter layer. In the system of claim 34, the filter layer is from one or more of the highly breathable polymer, polyurethane, polyamide, polyether blockamide, ethylene-vinyl acetate, polyvinyl alcohol, hydroxyacrylic, and carboxyacrylic. A system characterized by containing materials selected from the group consisting of. The system according to claim 34, further comprising a peeling layer detachably bonded to the mounting layer on the opposite side of the backing layer. The system according to claim 34, further comprising a support layer detachably bonded to the filter layer on the opposite side of the backing layer. In the system of claim 34.
A peeling layer that is peelably bonded to the mounting layer on the opposite side of the backing layer,
With a support layer detachably bonded to the filter layer on the opposite side of the backing layer
A system characterized by further providing.

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